MedTrace Logo

DRP-104 (Glutamine Antagonist) in Combination With Durvalumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)

NCT06027086 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-02-12

No results posted yet for this study

Summary

The purpose of this study is to determine whether the combination of subcutaneous DRP-104 in combination with intravenous Durvalumab is safe and yields a clinically compelling antitumor activity measured as based on objective response rate (ORR, assessed by RECIST 1.1). Secondary objectives include progression-free survival (PFS) and overall survival (OS).

Conditions

  • Fibrolamellar Hepatocellular Carcinoma

Interventions

DRUG

Durvalumab

Patients will receive treatment on Day 1 of each cycle. Durvalumab (1500 mg) will be administered IV on Day 1 of each cycle every 28 days.

DRUG

DRP-104

Patients will receive treatment twice a week of each cycle. DRP-104 (145 mg,125mg, 105mg, 85mg or 65mg) will be administered subcutaneous injection twice a week of each 28 day cycle. After the first cycle of treatment the study drug may be shipped to the patient's home for future cycles of administration if patients or caregiver can demonstrate at least two observed independent injections of DRP-104 prior to home administration.

Sponsors & Collaborators

  • Dracen Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Fibrolamellar Cancer Foundation

    collaborator OTHER

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Marina Baretti, MD · SKCCC • Johns Hopkins Medical Institution

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-12
Primary Completion
2028-09-01
Completion
2033-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06027086 on ClinicalTrials.gov